ITAMIDOL CUT 50G 3%

ITAMIDOL 3%

active ingredients

100 g ITAMIDOL 3% Skin foam contains 3 g diclofenac. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium hydroxide; macrogolglycerides; hydrogenated soy lecithin; polysorbed 80; benzyl alcohol; potassium sorbate; sodium phosphate dibasic dodecaidrate; all-rac-α-tocopherle acetate; scent mint/eucalyptus; purified water.

Therapeutic indications

Local treatment of painful and phlogistic states of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to diclofenac or any of the excipients. Hypersensitivity to other non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid. Patients in which asthma, urticaria or acute strokes occurred after taking acetylicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). Hypersensitivity to isopropanol. Third quarter of pregnancy. Itamidol contains soy. If you are allergic to peanuts or soy, do not use this medicine. Children and teenagers: Use in children and adolescents under the age of 14 is contraindicated.

Population

Posology. Adults over 18 years: Apply ITAMIDOL 3% Skin foam 1-3 times daily or second prescription. For each application spray on the palm of the hand, depending on the size of the area to be treated, a circular foam mass of 3-5 cm in diameter (equal to about 0.75-1.5 grams in weight) gently massaging until completely absorbed. In case of treatment for ionophoresis the product must be applied to the negative pole. ITAMIDOL 3% Skin foam can also be used in combination with ultrasound therapy. After the application, wash your hands, otherwise they will also be treated with the skin foam. Caution: use only for short periods of treatment. Teenagers from 14 to 18 years: Apply ITAMIDOL 3% Skin foam 1-3 times daily or second prescription. For each application spray on the palm of the hand, depending on the size of the area to be treated, a circular foam mass of 3-5 cm in diameter (equal to about 0.75-1.5 grams in weight) gently massaging until completely absorbed. In case of treatment for ionophoresis the product must be applied to the negative pole. ITAMIDOL 3% Skin foam can also be used in combination with ultrasound therapy. After application, wash your hands, otherwise they will also be treated with skin foam. If this product is necessary for more than 7 days to relieve pain or if symptoms worsen, consult your doctor. Children under 14 years: Insufficient information on effectiveness and safety in children and adolescents under 14 years (see also section 4.3 Contraindications) Therefore the use of ITAMIDOL 3% Skin foam is contraindicated in children under 14 years of age. Seniors: The usual dosage for adults can be used. Method of administration: shake before use. At the end of the cylinder, deliver the desired quantity by pressing the appropriate dispenser.

Conservation

Store at temperature below 30°C. Pressure recipient: ITAMIDOL 3% Skin foam contains flammable propellant. Protect against sun rays and do not expose at a temperature greater than 50°C. Keep away from any source of combustion.

Warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on extended skin areas and for a prolonged period (see the summary of the product characteristics of systemic forms of diclofenac). The topical Diclofenac must be applied only on intact, unsick skin, and not on skin wounds or open injuries. It should not be let into contact with mucous membranes or eyes and should not be ingested. In elderly and/or gastric patients we do not recommend the concomitant use of systemic anti-flogistic drugs. Asthmatic patients, with chronic obstructive diseases of bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasmal polipo) react with asthmatic attacks, local inflammation of the skin or mucosa (Quincke edema) or urticaria to the anti-rheumatic treatment performed with NSAIDs more often than other patients. In order to reduce any awareness-raising phenomena, it is advisable not to expose yourself to the sun during use. Keep the medicine out of reach and view of children. The use of ITAMIDOL 3% Skin foam, especially if prolonged, can give rise to local phenomena of sensitization, which impose the interruption of treatment and the adoption of adequate therapeutic measures. Stop the treatment if you develop skin rash after application of the product and consult your doctor. The topical diclofenac can be used with non-occlusive bandages, but should not be used with an occlusive bandage that does not let air pass.

Interactions

Since systemic absorption of diclofenac as a result of a topical application is very low, such interactions are very unlikely. However, in high dose treatments and protracted over time, the possibility of competition between absorbed ITAMIDOL and other high-linked drugs with plasma proteins is taken into account.

Effects

Systemic absorption of diclofenac following treatment with ITAMIDOL 3% Skin foam, is very low and therefore the risk of systemic effects is limited. However, as a result of applications on large skin surfaces for long periods of time, it is not possible to exclude, due to the active ingredient that is absorbed, the appearance of unwanted effects especially at gastroenteric level. Adverse reactions (Table 1) are listed by frequency, first the most frequent, using the following convention: common (≥ 1/100, Table 1

Immune system disorders
Very rare	Hypersensitivity (including hives), angiourotic edema.
Infections and infestations
Very rare	Rash with pustles
Respiratory, chest and mediastinic pathologies
Very rare	Asthma
Pathologies of skin and subcutaneous tissue
Town	Rash, eczema, erythema, dermatitis (including contact dermatitis), itching.
Rare	Bold dermatitis.
Very rare	Photosensitivity reaction
Notable	Feeling of burning in place of application, dry skin

The use of the medicine in association with other drugs containing diclofenac can lead to severely evolving skin reactions ( Stevens-Johnson syndrome, Lyell syndrome). Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The low systemic absorption of the topical diclofenac causes an overdose to be very unlikely. However, side effects similar to those observed after overdosing diclofenac tablets can be expected in case topical diclofenac was inadvertently ingested (1 50 g bottle of product contains the equivalent of 1.5 g diclofenac). In case of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs must be taken. They must be taken into account, especially within a short time of ingestion, gastric decontamination and the use of activated carbon.

Pregnancy

: The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to the experience with treatment with NSAIDs for systemic administration, we recommend the following: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy diclofenac should not be administered if not in strictly necessary cases. If diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must be kept as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Nursing:

Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at the therapeutic doses of ITAMIDOL 3% Skin foam is not expected to affect the infant. Due to the lack of controlled studies in nursing women, the product should be used during breastfeeding only under the advice of a healthcare professional. Under this circumstance, ITAMIDOL 3% Skin foam should not be applied on the breasts of nursing mothers, or elsewhere on extended areas of skin or for a prolonged period of time (see paragraph 4.4).

Fertility

: The administration of ITAMIDOL 3% Skin foam should be suspended in women who have fertility problems or who are subject to fertility surveys.

Source: Farmadati